Method of preparing a ready-to-use urinary catheter and a catheter assembly for use in said method

ABSTRACT

A method of preparing a ready-to-use catheter by providing a catheter assembly that has a first compartment that includes a catheter therein. The catheter includes on at least a part of its surface an exterior coating designed to reduce the coefficient of friction after treatment with a liquid swelling medium, and a second compartment containing a liquid swelling medium. The method includes sterilising the catheter assembly, adding the liquid swelling medium to the first compartment for wetting/activating the exterior coating of the catheter, and storing the ready-to-use catheter. By using the method according to the invention, the sterilisation of the catheter is effectuated in a dry-state, ensuring that the known problems with wet-sterilisation are completely eliminated and the need for preparing complicated and expensive liquid swelling mediums are no longer required.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is continuation of U.S. patent application Ser. No.15/840,571, filed Dec. 13, 2017, which is a continuation of U.S. patentapplication Ser. No. 14/438,589 filed Apr. 24, 2015, which is a 371filing of International patent application no. PCT/DK2013/050342 filedOct. 25, 2013, which claims priority to Danish patent application no. PA2012 70662 filed Oct. 26, 2012, the entire contents of each of which areincorporated herein by reference.

BACKGROUND

The present invention relates to a method of preparing a ready-to-usecatheter, a catheter assembly for use in said method, and a ready-to-usecatheter obtained by said method.

Urinary catheters having exterior coatings have been known for manyyears. Typically the coating is a hydrophilic layer designed to reducethe coefficient of friction in the wet condition, so that the cathetermay be inserted relatively painlessly into the urethra of the patient,and likewise removed therefrom when required.

In one type of catheters having exterior coatings the wetting fluid isinitially kept separate from the hydrophilic surface, and releasedimmediately prior to use, thereby activating the hydrophilic surface. Inanother type of such products, the wetting fluid is arranged in such away that the hydrophilic surface is maintained constantly wetted, andthereby ready for immediate use.

Catherisation means greater risk for infection in the urinary tract, andthe increase in multi-drug resistant organisms, combined with thewell-documented costs of treating healthcare-associated infections, hasled to a strong mandate to address and eliminate all potential avenuesfor infection.

To reduce risk of infection, the urinary catheter as well as the wettingfluid needs to be sterilised. Furthermore, the surface of the urinarycatheter should preferably remain uncontaminated prior to use.

Sterilisation of medical devices is typically performed at the time ofmanufacture, using techniques well known in the art such asbeta-irradiation or fumigation with ethylene oxide gas.

However, sterilization of a wetted catheters e.g. an intermittenturinary catheter with a hydrophilic coating, is in general regardedcumbersome if not impossible, using the conventional techniques.

If gas, e.g. ethylene oxide, is used it must be allowed to have accessto the catheter surface. However, the large volumes of wetting fluidsurrounding the catheter will act as a barrier, preventing efficientpenetration of ethylene oxide though the fluid. This means that themanufacturing process is made more complicated than would be desirable,requiring long and expensive periods of fumigation, andwet-sterilisation with fumigation is therefore generally regardedimpossible.

Sterilisation using irradiation of coatings in the activated state, hasthe well-known problem that an undesirable cross-linking of said coatingoccurs, removing the coatings abilities to retain water. This has theconsequence that the coefficient of friction increases undesirable whenthe catheter is stored in the wet, i.e. activated state.

One way of overcoming this problem is known from EP2303346, whichdiscloses that by adding one or more buffers to the wetting fluids, itwill be possible to prevent the pH-value of the activated hydrophiliccoating dropping to levels that promote acid formation during wetsterilization and subsequent storage, thereby preventing ruining thecoating on the catheters.

Another way of overcoming said disadvantages, is disclosed in EP1131112,describing that the water retention can increase dramatically andconsequently the initial coefficient of friction be kept low, bycarrying out wet-sterilisation of a medical device if the aqueoussolution comprises hydrophilic polymers. According to EP1131112, wettinga hydrophilic coating with a polymer solution protects theabove-mentioned properties during exposure to sterilisation usingradiation.

However, for catheters which are sterilised wet, the coating of thecatheter will either loos its water retention ability or obtain anundesirable increase in the coefficient of friction, unless specificcompounds, such as buffers or polymers, are added to the wetting fluid,or unless other specific requirements are met, making the manufacturingprocess expensive and complicated.

Another problem is that the hydrophilic coatings of catheters, which aresterilised and stored wet, tend to lose their water retention abilities,resulting in increases in the coefficient of friction. Thus, theeffective life of the catheters are limited or even over by the time thecatheter is utilized.

The above problems are the main reason why catheters conventionally aresterilised in a dry condition, and why the wetting fluid is keptseparate from the hydrophilic surface, and released immediately prior touse, as disclosed e.g. in EP0923398, EP1958656, US2003/0055403 andEP2545952.

The provision of the wetting fluid in a catheter assembly as disclosedin e.g. EP0923398 entails many advantages. For example, there is no needto find a water supply, and catheterisation can constantly be performedin any location and at any time. Further, the entire activation/wettingprocess can be performed under sterile conditions, without opening ofthe package.

However, a drawback with the catheters requiring activation/wettingimmediately before use is that the methods of wetting are relativelycomplicated, making the wetting process tedious and difficult to performby e.g. disabled users, such as tetraplegics or sclerosis patientshaving poor dexterity. Further, there is a significant risk that aninadequate wetting would occur from time to time, which would be bothpainful and potentially harmful for the user. Furthermore, in order toensure a proper wetting, a substantial amount of wetting fluid isrequired, and in most products of this type, the wetting fluid in itselfforms a substantial part of the overall weight of the product, makinglogistics more complicated and expensive.

In order to solve this problem, a vapour hydrated catheter assembly hasbeen suggested in EP2060296. However, activation of the catheterscoating using vapour, can result in inadequate wetting of the coating,which as discussed above will be both painful and harmful for the user.Furthermore, since only vapour is used for activating the catheter'scoating in EP 2060296 the catheter assembly is a very complexconstruction and accordingly expensive to manufacture.

Thus, there is a requirement for providing a ready-to-use catheter inwhich the wetting fluid does not comprise expensive and complicatedcomponents in order to ensure that the coating can be maintained for asustained period, where inadequate activation of the coating isprevented, and where the overall weight and size of the final catheterproduct is reduced more than hitherto known.

SUMMARY OF THE INVENTION

Therefore, it is a first aspect of the present invention to provide aready-to-use catheter, which safely and effectively can be inserted intothe urethra of the patient without causing discomfort.

It is a second aspect of the present invention to provide new ways ofproviding the sterilisation of a ready to use catheter to be carried outwithout detrimental effect to the water retention and the initialfriction of the coating.

It is a third aspect of the present invention to provide a method forobtaining sterilized catheters without compromising the integrity of thesterilization.

It is a fourth aspect of the present invention to provide a ready-to-usecatheter that allows for maximum shelf life of the catheter.

In a fifth aspect according to the present invention is provided acatheter that is inexpensive to manufacture and is simple and reliableto use.

In a sixth aspect according to the present invention is provided acatheter that are relatively small and easy to operate, especially byone hand.

The novel and unique features whereby these and further aspects areachieved according to the present invention is the fact the method forpreparing a ready-to-use catheter, comprises

-   -   providing a catheter assembly, comprising a first compartment        comprising a catheter, said catheter comprises on at least a        part of its surface an exterior coating arranged to reduce the        coefficient of friction after treatment with a liquid swelling        medium, and a second compartment comprising the liquid swelling        medium,    -   sterilising the catheter assembly,    -   adding the liquid swelling medium to the first compartment for        wetting the catheter's exterior coating, and    -   storing the ready-to-use catheter.

First of all, by using the method according to the invention, thesterilisation of the catheter is effectuated in a dry-state beforeactivation with liquid swelling medium, ensuring that the known problemswith wet-sterilisation are completely eliminated and the need forpreparing and controlling complicated and expensive liquid swellingmediums are no longer a requirement.

After sterilization of the catheter assembly the liquid swelling mediumis added to the compartment containing the catheter understerile/aseptic conditions by emptying the liquid content of the secondcompartment inside the sterile/aseptic boundaries of the catheterassembly. When the catheter's exterior coating comes into contact withthe liquid swelling medium, said coating is activated, i.e. said coatingswells to a smooth, slippery film making the catheter safe by reducingfriction during insertion and withdrawal.

In the context of the present invention, “adding the liquid swellingmedium”, means that the swelling medium is added to the compartment inliquid form, i.e. that no phase change of the medium is required beforethe medium can be added. This not only provides a very simpleembodiment, but also ensures that direct and sufficient contact of theliquid swelling medium with the entirety of the catheter's exteriorcoating is obtained, thereby preventing inadequate activation of thecoating. In this respect it is preferred that when the liquid swellingmedium is added to the first compartment, said medium has unobstructedaccess to the first compartment without any demands of physical phasechanges e.g. liquid to vapour, in order to ensure a fast and efficientactivation of the coating.

As the liquid swelling medium is added to the first compartment afterthe sterilisation is completed, but before the catheter is distributedto the end users, the activated low friction character of the coatingwill keep the catheter in a ready to use condition at all times.Furthermore, problems with inadequate wetting are eliminated, and thetime-consuming and inconvenient method of wetting/activating thecatheter immediately before use is no longer required for the user. Thishas the inherent advantage that no further preparation is required priorto use, so that the operation will be reduced to immediate withdrawal ofthe catheter from the first compartment, without the delay resultingfrom any required wetting period.

Within the context of the present invention the term “ready-to-usecatheter” means a catheter in which the exterior coating designed toreduce the coefficient of friction has been treated with a liquidswelling medium, i.e. the coating is maintained constantly wetted andthe catheter is therefore ready for immediate use.

Accordingly the catheter according to the present invention can be useddirectly by end users in any location, also outside the medicalenvironment of a hospital or a clinic, as the requirement of access to atoilet and/or water is eliminated. Furthermore, since no furtherpreparation is required prior to use the catheter is especiallyadvantageously for e.g. by tetraplegic patients who often have a verypoor dexterity, and therefore need a very simple insertion procedure.

During storage the first compartment not only acts as a cover ensuringthat the surface of the urinary catheter remains uncontaminated prior touse, but said compartment can also functions as a protective sleeveenabling the user to hold the urinary catheter during catheterisationwithout it slipping due to the coating and without contaminating thesterilised surface.

It must be stressed, that the inventors surprisingly have discovered,that since the activation, i.e. addition of the swelling medium to thecatheter, is effectuate, after the sterilisation is complete, thecatheter can be stored without loosing its water retention ability andwithout obtaining an unadvantageous increase in the coefficient offriction.

In a preferred embodiment the method further comprises removing thesecond compartment from the catheter assembly after the liquid swellingmedium has been added to the first compartment.

In order to ensure that the activated sterilised surface is notcontaminated in this respect, it is preferred that the removal of thesecond compartment is effectuated by a method which does not compromisethe sterility of the content of the first compartment.

In this respect, the second compartment can be removed from the catheterassembly using any conventional method as long as the first compartmentcontaining the activated catheter is maintained sterile. In a preferredembodiment the second compartment is removed by e.g. die-cutting,welding and/or sealing e.g. by heat or glue, as said methods are bothsimple and inexpensive.

In a preferred embodiment the method according to the invention canfurther includes a process step for providing a hanger/strap in thecatheter assembly or in proximity/adjacent to the first compartment.Said hanger/strap is intended for supporting handling of the catheter bysuspending the package comprising the catheter on a wall, e.g. of arestroom. Fixation in hanging position could alternatively be providedby one or more sticky dot(s) mounted on the final package.

In addition or as an alternative, an easy-to-grip handle can be preparedin a final packaging comprising the activated catheter, e.g. inproximity to the first compartment. Said step(s) can e.g. be performsimultaneously with removing the second compartment, or in a separatestep subsequent to removal of said second compartment.

The hanger/strap and/or easy-to-grip handle can in a preferredembodiment be prepared by reprocessing the second compartment, oralternatively be prepared in a part of the catheter assembly which doesnot contain the first or second compartment, e.g. in an intermediatesection between said two compartments, or in a separate section placedin proximity to the first compartment, and is effectuated using e.g. dyecutting or similar methods.

Removing the second compartment before the catheter is placed instorage, not only means that the stored product will have a smallersize, but also that the liquid swelling medium present in the firstcompartment, will be lower than in e.g. the products where a separatedosage of liquid swelling medium is part of a stored catheter assembly,as e.g. known from EP0923398.

In the known products of this kind a substantial amount of wetting fluidis required in order to ensure a proper wetting, adding to the overallweight and size of the product.

In contrast, the method of the present invention provides the advantage,that any excess swelling medium, i.e. liquid swelling medium which isnot used for activating the coating of the catheter, can be removed fromthe catheter assembly prior to storage, preferably simultaneously withor during the process of removing the second compartment from thecatheter assembly.

Consequently, essentially all the swelling medium remaining in the firstcompartment after removal of the excess medium, is in this way used forits intended purpose, viz. has been assimilated by the coating, and theweight of the swelling medium in the final catheter packaging istherefore reduced to only slightly more than the wetting fluid containedin the coating when activated. The lower weight and size result insmaller packages, which makes the production easier and less costly, andalso makes the products easier and less expensive to handle and store.

A further advantage of minimizing the amount of excess liquid swellingmedium is that it avoids dripping from the tip of the catheter. Drippingis a known disadvantage of catheters stored wet.

In order to reduce the overall weight and size of the final product, thefirst compartment can in a first embodiment comprise a cavity, whichvery narrowly encloses the part of the catheter being provided with thecoating. This results in a very lean and light product, where a verylimited amount of water is sufficient to ensure an easy and highlyeffective activation of the entire coating. This also ensures, thatexcess amounts of liquid cannot spill from the package when the packageis opened and thereby wet and/or stain the end user's clothing.

In a different embodiment excess liquid fluid medium and/or airsurrounding the catheter can be removed by vacuum suction, preferablyduring removal of the second compartment. In this way a minimum weightof the product is obtained, as the only liquid remaining in the firstcompartment, is the liquid in the activated coating. Since air is alsoremoved from the compartment, the size of the product can be reduced toa minimum and the fluid will be forced to be present only around thecatheter, ensuring that smaller amounts of liquid swelling medium isrequired in order to activate the coating.

When a vacuum suction step is introduced in the method according to theinvention, it is preferred that the first compartment is designed fornot having any sharp edges which could damage the activated coating, oralternatively that the first compartment has a size and design whichensures that any sharp edges present in the first compartment are notbrought into contact with the activated coating when the vacuum suctionhas been completed.

Vacuum can be provided on the first compartment in any convenientlocation using any conventional means, as long as the activated catheteris maintained sterile. In this respect it is preferred that the vacuumsuction is applied to the catheter assembly during removal of the secondcompartment, e.g. by attaching the vacuum suction equipment to thesecond compartment, ensuring that any openings into the firstcompartment will be efficiently closed by e.g. welding and/orheat-sealing without providing any openings into the first compartment.It is in this respect preferred that the second compartment comprisese.g. a one-way valve which prevents the interior of the catheterassembly to be contaminated during attachment of the vacuum equipment.Said one-way valve can in a preferred embodiment be made of a gasdiffusible material such as Tyvek®, which preferably also isincorporated into some embodiments of the catheter assembly when agas-sterilisation is contemplated.

Since the sterilisation of the catheter assembly in the method accordingto the invention, is effectuated when the catheter is in its dry state,any conventional form for sterilisation can be used, as long as theintegrity of the catheter is not compromised, e.g. by excessive heat orsteam. It is important that all parts of the catheter assembly issterilised, including the liquid swelling medium, in order to reducerisk of infection. The preferred sterilisation method includes, but isnot limited to, the widely used industrial sterilizations technologiessuch as ethylene oxide, and γ- and β-irradiation. However, other methodscan also be contemplated within the scope of the present invention, suchas low-temperature hydrogen peroxide gas plasma, low-temperatureperacetic acid gas plasma, vapour-phase hydrogen peroxide, ozone,chlorine dioxide, and high-intensity visible light.

In a simple and efficient method according to the invention ethyleneoxide is a preferred method of sterilisation because of its undeniableadvantages as an exceptional sterilizing agent having bactericidal,sporicidal, and virucidal activity. Ethylene Oxide sterilization isknown in the art for sterilizing medical devices that cannot supportconventional high temperature steam sterilization—such as devices thatincorporate electronic components, plastic packaging or plasticcontainers. Said method is therefore well known in the art and will notbe discussed in further details.

The liquid swelling medium can be added to the first compartment at anytime before the catheter is placed in storage, however it is preferredthat the swelling medium is added to compartment containing the catheterimmediately after sterilization of the catheter assembly, i.e. when thecatheter is still in the production facilities. In this way theactivation process can be monitored and controlled, ensuring that anadequate activation/swelling of the catheter's coating is obtained.

A problem often encountered with the known coated catheters intended foractivation immediately prior to use, is that the surface of the cathetercan become sticky and adhere to the paper of the package causing thecoating on the catheter to be damaged, destroyed or mutilated, resultingin inadequate wetting. When the swelling medium is added to the catheterimmediately after sterilisation, as in the present invention, saidproblem is completely eliminated.

Within the context of the present invention, the term “immediately aftersterilisation” means that the catheter assembly is still present in theproduction facilities and has not been relocated to a storage facilityas finished goods for distribution to customers.

It is preferred that the liquid swelling medium is added to the firstcompartment as soon as possible after the sterilisation process iscompleted, and that said step is the next in the production line of thefinal catheter. However, a person skilled in the art will understandthat if e.g. ethylene oxide sterilization is used, the catheter assemblyneed to go through a degassing phase to remove any particle of ethyleneoxide from the first and second compartment, in order to prevent anyundesirable by-products, e.g. the toxic ethylene glycol, when the liquidswelling medium is added to the first compartment. Such a degassingphase is accordingly not needed when the sterilisation is performedusing radiation.

Thus, the term “immediately after sterilisation” means as soon aspossible after the sterilisation step is completed and at a time whenthe liquid swelling medium can be added without any harmful sideeffects.

The present inventors have found that using the method according to theinvention the activated sterilised ready-to-use catheter can be storedfor a period exceeding the recommended shelf life time of the catheterwhich could be up to five years, typically 36 months, withoutdetrimental effect to the activated coating, including the parameters ofwater retention and initial friction of the coating.

The present invention also relates to a catheter assembly comprising afirst compartment comprising a catheter, said catheter comprises on atleast a part of its surface an exterior coating arranged to reduce thecoefficient of friction after treatment with a liquid swelling medium,and a second compartment comprising the liquid swelling medium, whereinthe second compartment is made of a gas-permeable material.

Conventionally the compartments containing the liquid swelling medium ismade of a gas-impermeable material, in order to prevent that any of theliquid can come into contact with the catheters coating for the wholelifetime of the catheter (typically 36 months). However, the inventorsof the present invention have surprisingly found that a certaingas-permeability through the walls of said compartment is an advantageduring the sterilization process thereby reducing process time andcosts. Especially when an ethylene oxide process is used, the inventorshas shown that the relatively small diffusion of gas from the secondcompartment to the first compartment will be sufficient to provide thedesired humidity in the first compartment in order to ensure a veryeffective ethylene oxide sterilization process. However, said smalldiffusion is still so low that it will not affect the activation of thecoating.

The term “gas-permeable” material should be understood in this contextof the present invention to mean any material that will provide a liquidbarrier before the liquid swelling medium is added to the firstcompartment, but will allow diffusion by evaporations of the actualliquid swelling medium.

In an especially advantageously embodiment the material can be chosenamong relatively cheap materials such as polyethylene (PE) andpolypropylene (PP), poly-ethylene-Vinyl-Acetate (EVA); andPoly-vinyl-chloride (PVC) thereby providing an inexpensive product.

Due to the relatively short duration the liquid swelling medium has tobe present in the second compartment before it is added to the firstcompartment for activation of the coating, gas-impermeability of thesecond compartment is not demanded in the present invention since theloss of liquid swelling medium through a gas-permeable barrier will benegligible after a few days or weeks compared to duration of 36 months,and in the present invention said gas-permeability has even proven to behighly favourable.

Since the second compartment is gas-permeable this part is preferablyeither sealed of or removed from the remaining catheter assembly, e.g.by heat sealing or welding after sterilisation. Alternatively the entirecatheter assembly can be wrapped in a gas-impermeable package in orderto maintain stability of the product during the intended lifetime.

It is preferred that the gas-impermeable parts of the catheter assemblyis sealed off from the gas-permeable parts during the removal of thesecond compartment, as described above.

When the catheter assembly is wrapped in an outer gas-impermeablepackaging, and gas-sterilisation e.g. ethylene oxide sterilisation iscontemplated, part of the outer packaging preferably comprises anintermediate section which consists of a gas diffusible bacteria barrierthat allows for gas-sterilization, e.g. made of a Tyvek®-material orother paper based materials with similar properties, and arranged suchthat both the first and second compartment can be sterilised. If such agas diffusible bacteria barrier is present this must later be sealed ofor removed from the remaining catheter assembly, e.g. by heat sealing orwelding as described above, in such a way that the activated catcher isstored in an gas impermeable packaging.

The first compartment can either be placed inside the outer packaging,be combined with said packaging or be formed directly in said packaging.In the latter embodiment, the first compartment is identical with asection of the outer packaging.

In a preferred embodiment according to the invention, the catheterassembly further comprises a collection bag arranged for collectingfluid e.g. urine during catheterisation. Said collection bag ispreferably contained within or constitutes parts of the sterileboundaries of the outer packaging.

The collection bag is preferably not in liquid communication with theinterior of the first compartment during storage, in order to ensurethat liquid swelling medium will remain in close contact with thecatheters coating. The opening between the collection bag and the firstcompartment is therefore preferably closed by a drainage closure. Saiddrainage closure is preferably a releasable closure, arranged such thata liquid communication path can be established between the firstcompartment and the collection bag without perturbation of the sterilityof the catheter.

The drainage closure can be any kind of closure, which can be opened todrain fluid through the catheter to the collection bag duringcatheterisation. Said closure can e.g. be fixed folding of the packagingwhere the closure is opened by unfolding said folding, a peel weldingactivated by external forces, an external clamp closure or an internalplug that can be removed by external forces.

If the catheter packaging comprises a collection bag, it is preferredthat when the catheter packaging is opened, the catheter can be trappedin the first compartment, allowing said compartment to function as aconnecting hose between the catheter and collecting bag duringcatheterisation, allowing fluid, e.g. urine to flow into the collectionbag through the catheter.

The packaging and/or catheter assembly can in a preferred embodiment bemade of e.g. two sheets of film material that e.g. are welded togetherand comprising a welded joint. Such a welded joint may comprise a partprovided as a peelable joint permitting separation of said sheets fromeach other for withdrawal of said catheter from the package.

Placing the catheter assembly into an outer packaging, is not onlyrelevant if the first compartment is made of a gas-permeable materialbut also if said compartment is made of a soft and/or very flexiblematerial which could rupture or brake and accordingly compromise thesterility of the first compartment when said material is subjected tohandling during storage or transport.

It is preferred that the catheter assembly is arranged for easy openingand withdrawal of the catheter, and also that they are designedcomprising an easy-to-grip handle that improves control during insertionand keeps fingers away from the sterile part of the catheter. It isadvantageously if the packaging and/or catheter assembly in addition tomaintaining the sterility, also is adapted to protecting the catheter,e.g. from sunlight, rough handling, or transportation. Packaging of thiskind is also well known in the art.

One preferred example of a tear open system dedicated for users with lowdexterity comprises tear marks placed in the lower part of thepackaging/first compartment between to handgrips. The packaging can beforced open by forcing the two handgrips from each other, and the tip ofthe package can be used as a “none touch” to withdraw the catheter fromthe packaging.

In a preferred embodiment the second compartment comprises an outlet fordischarging the liquid swelling medium into the first compartment, saidoutlet is closed by a releasable closure. Said closure can be any kindof closure which can be opened to expel the liquid swelling medium intothe first compartment without compromising the sterility of the catheterassembly.

In one preferred embodiment said releasable closure is a rupturableclosure in the form of a membrane or welding providing a relativelyfaint joint, which will be ruptured by applying pressure on the secondcompartment, thereby allowing the swelling medium to be in liquidcommunication with the interior of the first compartment.

In a different embodiment the second compartment can be compressible,having an outlet, which is arranged for being in fluid communicationwith an opening of the first compartment, when the releasable closure isreleased. The advantage of a compressible compartment is that all theliquid swelling medium easily can be forced into the first compartment,ensuring a sufficient activation of the coating. Thereby, thepreparation of the catheter with the liquid swelling medium can be madevery simple by application of a pressure to the walls of thecompartment, whereby the liquid swelling medium will be transferred tothe first compartment.

In a further embodiment the releasable closure is in the form of arupturable membrane, connected with an operating device permittingrupturing of the membrane without opening the catheter package. Saidoperating device can e.g. comprise a rod-like member connected with themembrane and extending throughout the length of the second compartmentand through an end wall of second compartment to a pulling member. Whena pulling force is applied to said member, the membrane will rupturewhereby the liquid swelling medium content in the second compartmentwill flow into the first compartment. In order not to compromise thesterility of the catheter assembly said rod-like member and pullingmember is preferably contained within the outer walls of the catheterassembly.

In the above-mentioned embodiments the first compartment is not closed,only the second compartment is closed by the releasable closure, andwhen the releasable closure is opened the two compartments are in directfluid communication. In a different embodiment the first compartment canalso be closed by a releasable closure e.g. by placing an intermediatelayer or membrane between the two compartments.

In a different embodiment the second compartment is made of a degradablematerial, which will dissolve within a few weeks, such that the liquidfluid medium automatically will be added to the first compartment aftera time period. Said embodiment is especially advantageously when thesterilisation of the catheter assembly is performed using ethyleneoxide, as this inherently will ensure that the degassing phase iscompleted before the coating is activated. Furthermore, since the liquidswelling medium automatically will be added to the first compartment,the catheter assembly can be directly placed in storage.

It is preferred that the first compartment comprises a cavity, whichvery narrowly encloses the part of the catheter being provided with thecoating. This results in a very lean and light product, where a verylimited amount of water is sufficient to ensure an easy and highlyeffective activation of the entire coating.

Within the context of the present invention the term “exterior coating”means any kind of layer placed on at least a part of the exterior of thecatheter. In this respect it is not relevant if the coating is an outeradherent layer, a co-extruded layer, or a conventional coating, the onlyrequirement is that the catheter comprises an outer layer designed toreduce the coefficient of friction in the activated condition.

In a preferred embodiment the coating is a hydrophilic coating, as theseare well known in the art to reduce catheter-associated complicationsand to improve patient comfort and acceptance. These catheters arecharacterised by having a layer of polymer coating that is bound to thecatheters surface. WO 94/16747 discloses a hydrophilic coating, whichcan be used in the present invention. Said coating improves retention ofwater on a surface, especially a surface of a medical device such as anintermittent urinary catheter, and is prepared by applying to thesurface in one or more process steps at least one solution of componentsthat will combine to form the hydrophilic coating. During the final stepthe surface is coated with an osmolality promoting agent, which isdissolved or emulsified in the solution or in the last solution to beapplied when forming the hydrophilic coating. In order to maintain thelow friction surface character during location of the catheter in theurethra and subsequent withdrawal therefrom and hereby reduce stingingpain it is further preferred to incorporate an osmolality promotingagent, such as NaCl, in the hydrophilic coating. The osmolalitypromoting layer disclosed in WO 94/16747 is optional regarding thepresent invention, as the liquid swelling medium can be saline waterinstead of tap water.

Hydrophilic coatings further have the advantage that the liquid swellingmedium can be water or a saline solution i.e. a solution of 0.90% w/v ofNaCl, or even higher concentrations in order to obtain hyper osmolalityof the coating. The salt is preferred for being able to adjust theosmolality, and both water and saline are very inexpensive materials.

In any case it is preferred that the liquid swelling medium is notcytotoxic and complies with current health and safety regulations. Inthis respect it is desired that said swelling medium does not containany hydrophilic polymers and/or any buffer components, in order toprovide a simple and inexpensive liquid swelling medium, but alsocomponents which could have a harmful or negative impact on the user orthe final product, should for obvious reasons be avoided.

In order to ensure that the activated, i.e. pre-lubricated andready-to-use, catheter maintains it water retention and reduced frictionforce, it is advantageously that the first compartment is made of agas-impermeable material, in order to prevent that the liquid which iscontained in the activated coating, can evaporate during the lifetime ofthe catheter.

The term “gas impermeable” material should be understood in this contextto mean any material that will be sufficiently tight against liquidlosses caused by vapour diffusion from an compartment containing theactivated coating for a period exceeding the recommended shelf life timeof the catheter assembly, which could be up to five years, typically 36months.

Said gas-impermeable material can be any suitable material, and can in apreferred embodiment be a gas impermeable thermoplastic film materialsuch as a multiple layer film material comprising e.g. aluminium.

Since catherisation sometimes must be performed outside the users normaldaily environment, e.g. in public toilets, where the general state ofcleanliness cannot be expected to be of a sufficiently high standard, itis highly relevant that the ready-to-use catheter is placed in a firstcompartment/packaging which preferably is be designed for easy openingand withdrawal of the catheter.

The invention also relates to a ready-to-use catheter obtained by themethod according to the present invention. Said catheter can be any kindof ready-to-use catheter including an intermittent catheter, anindwelling catheter, or a suprapubic catheter. Such catheters are allwell known in the art and will not be discussed in further details inthis application.

In some situations it may be preferred that several ready-to-usecatheter packaging are combined in a single overall packaging, therebyresulting in lower weight and size which makes the products easier andless expensive to handle and store, not only from a manufacturing pointof view but also for the intended end user. In such embodiments, it ispreferred that a single second compartment contains sufficient liquidswelling medium in order to active several catheters placed in eachtheir first compartment. Preferably the individual first compartmentsare mutually connected to each other via tear off lines. The swellingmedium can e.g. be distributed via a manifold, which optionally can beremoved from the first compartments together with the empty secondcompartment.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be explained in greater detail below, describing onlyexemplary embodiments of the irrigation device with reference to thedrawing, in which

FIG. 1 shows a first embodiment of a catheter assembly according to thepresent invention,

FIG. 2 shows a second embodiment of a catheter assembly according to thepresent invention,

FIG. 3 shows a third embodiment of a catheter assembly according to thepresent invention,

FIG. 4 shows a final package of the third embodiment according to theinvention, wherein the second compartment has been removed,

FIG. 5 illustrates a fourth embodiment of a catheter assembly accordingto the present invention, and

FIG. 6 shows a final package of the fourth embodiment according to theinvention, wherein the second compartment has been removed.

DETAILED DESCRIPTION OF THE INVENTION

The invention will be described below with the assumption that theexterior coating on the catheter is an intermittent catheter comprisinga hydrophilic coating and that the liquid swelling medium is a salinesolution. However, this assumption is not to be construed as limiting,and the catheter can just as easily be an indwelling catheter, or asuprapubic catheter, or a similar catheter.

FIG. 1 shows a first embodiment of a catheter assembly 1 according tothe present invention. Said catheter assembly 1 consist basically of afirst compartment 2 comprising the catheter 3, and a second compartment4 comprising the liquid swelling medium 5, which in the presentsituation is a saline solution. Said catheter comprises on at least apart of its surface 6 an exterior hydrophilic coating 7 designed toreduce the coefficient of friction after treatment with the liquidswelling medium.

The second compartment 4 comprises an outlet 8 for discharging theliquid swelling medium into the first compartment, said outlet is closedby a releasable closure 9.

In the embodiment shown said releasable closure 9 is a membrane 18providing a relatively faint joint, which will be ruptured by applyingpressure on the second compartment 4, thereby allowing the liquidswelling medium 5 to be in liquid communication with the interior of thefirst compartment 2 though an opening 10 in said compartment. However,within the scope of the present invention said closure can be any kindof closure which can be opened to expel the liquid swelling medium intothe first compartment without compromising the sterility of the catheterassembly.

The first compartment 2 comprises a cavity 11, which very narrowlyencloses the part of the catheter 3 being provided with the hydrophiliccoating. This results in a very lean and light product, where a verylimited amount of liquid swelling medium is sufficient to ensure an easyand highly effective activation of the entire coating.

In the embodiment shown the first compartment 2 is made of agas-impermeable material and the second compartment 4 is made of agas-permeable material. It is preferred that the gas-permeable parts ofthe catheter assembly i.e. the second compartment 4, is removed and/orsealed off from the first compartment 2 in order to maintain sterilityof the ready-to-use catheter during the intended lifetime. This ispreferably obtained by applying a seal (not shown) in an upper part 12of the first compartment 2, i.e. the part that is not containing thecatheter.

FIG. 2 shows a second embodiment 1′ of the catheter assembly accordingto the present invention. In said embodiment the catheter assembly 1 inFIG. 1 has been placed in an outer packaging 13. Said packaging 13 isarranged such that the first compartment 2 is part of said packaging,and the second compartment is placed inside the packaging. A gap 14 isprovided between the second compartment 4 and the packaging 13.

The second compartment 4 has been made of a gas-permeable material. Thepackaging 13, which constitutes the sterile boundaries, is in contrastmade of a gas-impermeable material in order to prevent that the liquidin the activated coating evaporates during the shelf life time of thecatheter. This will not only ensure that the liquid, which is containedin the activated coating, cannot evaporate during the lifetime of thecatheter, but also that any gas evaporating from the second compartment4, before the sterilisation step and before the liquid medium is addedto the first compartment, will be directed to the gap 14 allowing saidgas to diffuse to the first compartment 2, and into the interior of thefirst compartment 2. This will advantageously ensure that the humidityobtained thereby in the first compartment 2 provides a very effectiveethylene oxide sterilization process. The diffusion of gas from thesecond compartment to the first compartment will be sufficient toprovide the desired humidity in the first compartment in order to ensurea very effective ethylene oxide sterilization process, but still to lowto activate the coating.

A section 15 of the packaging 13 consists of a gas diffusible bacteriabarrier 16 e.g. made of Tyvek® that allows for gas-sterilization.

FIG. 3 shows a third embodiment 1″ of the catheter assembly according tothe present invention. Said embodiment corresponds basically to thecatheter assembly 1′ in FIG. 2. i.e., the second compartment 4 is placedinside an upper part of the packaging 13. As for the other embodiments1,1′ the second compartment also comprises a membrane 18 which will beruptured by applying pressure on the second compartment 4, therebyallowing the liquid swelling medium 5 to be in liquid communication withthe interior of the first compartment 2.

The embodiment in FIG. 3 however has the addition that it comprises anintermediate section 17, adapted for easy removal and/or sealing of thefirst compartment 2.

The catheter assembly 1,1′ and 1″ can be prepared by any conventionalmeans, and have any form or design. In the embodiments shown the secondcompartment 4 is placed at the upper end of the catheter assembly,however the second compartment 4 could equally well be placed in theopposite end or be placed on one or more sides of the first compartment2. The only requirement is that during the sterilisation of the catheterassembly 1,1′,1″ the catheter 3 is contained in the first compartment 2,whereas the liquid swelling medium is contained in the secondcompartment 4, and that the two compartments are not in liquidcommunication with each other.

Since the sterilisation is effectuated in the catheter's dry state, theknown problems with wet-sterilisation are completely eliminated and theneed for preparing and controlling complicated and expensive liquidswelling mediums are no longer a requirement.

After sterilization of the catheter assembly 1,1′,1″ the liquid swellingmedium 5 can conveniently be added to the first compartment 2 understerile/aseptic conditions by rupturing the membrane 18, by applyingforce to the second compartment 4. This will ensure that the hydrophiliccoating 7 comes into contact with the liquid swelling medium 5, wherebysaid coating is activated, i.e. said coating 7 swells to a smooth,slippery film 20 making the catheter 3 safe in use by reducing frictionduring insertion and withdrawal. Since the activation, i.e. addition ofthe swelling medium to the catheter is effectuate after thesterilisation is complete, the catheter 3 can be stored without loosingits water retention ability and accordingly without obtaining anunadvantageous increase in the coefficient of friction.

Since no further preparation is required prior to use, all the user hasto do it to withdraw the catheter 3 from the first compartment 2.Accordingly the catheter according to the present invention can be useddirectly by end users in any location, e.g. by tetraplegic patients.

During storage the first compartment 2 or the packaging 13 not only actsas a cover ensuring that the surface 6 of the catheter 3 remainsuncontaminated prior to use, but said cover can also functions as aprotective sleeve enabling the user to hold the urinary catheter duringintermittent catheterisation without it slipping due to the coating andwithout contaminating the sterilised surface.

Any gas-permeable parts of the catheter assembly according to theinvention, must preferably be removed and/or sealed off from theremaining catheter assembly, in order to maintain stability of thecatheter during the intended lifetime.

This can e.g. be effectuated at the same time as the second compartment4 is removed from the catheter assembly 1,1′,1″. It is preferred thatthe second compartment 4 is removed by e.g. welding and/or heat-sealing,as said methods are both simple and inexpensive and at the same timewill ensure that the first compartment 2 effectively is sealed off.

In FIG. 4 is shown final package 19 according to the invention where thesecond compartment has been removed. Said package include the activatedcatheter 3′, i.e. the coating 7 has been activated to provide a smooth,slippery film 20.

During the removal of the second compartment a hanger/strap 21 placed inproximity to the first compartment as been provided. Said hanger/strapis intended for supporting handling of the catheter by suspending thepackaging 13 on a wall, e.g. of a restroom. The hanger/strap is preparedin an intermediate section 17 of the catheter assembly, i.e. a sectionthat neither contains the first 2 or second compartment 4, nor the gasdiffusible bacteria barrier 16.

Removing the second compartment before the catheter package 19 is placedin storage, not only means that the stored catheter package 19 will havea smaller size, but also that the liquid swelling medium present in thefirst compartment has been used for its intended purpose and iscontained in the hydrophilic coating. The weight of the swelling mediumin the final catheter package is therefore reduced to only slightly morethan the wetting fluid contained in the coating when activated, alsoeliminating the known problems that dripping from the tip of thecatheter is avoided. The lower weight and size result in smallerpackages, which makes the production easier and less costly, and alsomakes the products easier and less expensive to handle and store.

FIG. 5 illustrates a fourth embodiment of the catheter assembly 1′″according to the invention. For like part the same reference numbers areused as for the previous embodiments.

In the present embodiment the second compartment 4, is not an extensionof the first compartment 2, but is instead placed as a projection,extending perpendicular to the first compartment 2. Said secondcompartment has in FIG. 6 been removed as described above, by applying aseal (not shown) in a section 12′ of the first compartment 2.

In addition to encasing the first and second compartment, the outerpackaging 13 further contains within its sterile boundaries, acollection bag 22 arranged for collecting urine during catheterisation.

The collection bag 22 is preferably not in liquid communication with theinterior of the first compartment 2 during storage, in order to ensurethat liquid swelling medium 5 which is not bound to the exterior coating7 will flow into the collection bag 22.

The opening between the collection bag 22 and the first compartment 2 isclosed by a drainage closure 23. Said drainage closure is a releasableclosure, arranged such that a liquid communication path can beestablished between the first compartment 2 and the collection bag 22without perturbation of the sterility of the catheter packaging.

An example of a tear open system 24 dedicated for users with lowdexterity is shown in FIGS. 5 and 6 where tear marks 25 are placedbetween to handgrips 26. When the package is forced open by forcing thetwo handgrips from each other, the tip of the package 27 is used as a“none touch” to withdraw the catheter 6 from the primary package 13until the catheters connector 28 is trapped in the first compartment 2just before the tear marks 25. The part 29 of the first compartment 2,which is connected to the collection bag 22, then functions as a kind ofconnecting hose between catheter 6 and collecting bag 22 duringcatheterisation, allowing urine to flow through the catheter into thecollection bag thereby providing a very hygienic system, which can beused at any location. After catheterisation the catheter 6 can bydropped back in the collecting back 22 and a knot can be tied on thepackaging 13 thereby closing the system, which is now ready to be thrownaway.

The ready-to-use catheter according to the invention has a simple andinexpensive design, and can therefore be used equally well for bothprivately and in medical or hospital facilities where known cathetersare too troublesome and complicated to use.

Modifications and combinations of the above principles and designs areforeseen within the scope of the present invention.

What is claimed is:
 1. A method of preparing a ready-to-use catheter,said method comprising: in a first step, providing a catheter assembly,comprising: i. a catheter disposed in a first location, said cathetercomprising on at least a part of its surface an exterior coatingarranged to reduce a coefficient of friction after treatment with aswelling medium, and ii. a swelling medium disposed in a secondlocation, said catheter assembly being wrapped or placed in agas-impermeable package; in a second step, sterilizing the catheterassembly, in a third step, transferring the swelling medium to the firstlocation under sterile conditions inside sterile boundaries of thecatheter assembly to wet and activate the exterior coating, wherein saidtransferring occurs when the catheter assembly is in one or moreproduction facilities, and in a fourth step, storing the ready-to-usecatheter, wherein the first step is executed before the second step, thesecond step is executed before the third step, and the third step isexecuted before the fourth step.
 2. The method according to claim 1,wherein the sterilizing of the catheter assembly is performed by γ- orβ-irradiation.
 3. The method according to claim 1, wherein the swellingmedium is transferred to the first location immediately aftersterilizing of the catheter assembly.
 4. The method according to claim1, wherein the ready-to-use catheter can be stored for a period of atleast 36 months.
 5. The method according to claim 1, further comprisingremoving any excess swelling medium and/or air present in the firstlocation after the catheter exterior coating has been wetted/activated.6. The method of claim 1, comprising forming as an intermediate product,a sterilized catheter assembly comprising a first compartment containingthe catheter that has on at least a part of its surface the exteriorcoating that can provide a reduced coefficient of friction whencontacted with the swelling medium, and a second compartment containingthe swelling medium, wherein the catheter assembly is sterilized withthe first compartment in a dry state prior to contact of the catheterexterior coating with the swelling medium.
 7. The method of claim 6,wherein the second compartment of the catheter assembly comprises anoutlet for discharging the swelling medium, said outlet being closed bya releasable closure and the outlet is arranged in fluid communicationwith an opening of the first compartment, when the releasable closure isreleased.
 8. The method of claim 7, wherein the releasable closure is arupturable closure.
 9. The method of claim 8, wherein the rupturableclosure is in the form of a membrane or welding, which is ruptured byapplying pressure on the second compartment.
 10. The method of claim 8,wherein the rupturable membrane is connected with an operating devicearranged for rupturing the membrane without opening the catheterpackage.
 11. The method of claim 6, wherein the second compartment is acompressible compartment.
 12. The method according to claim 1, furthercomprising providing a hanger or strap or handle attached to thecatheter assembly.
 13. The method of claim 1, wherein the exteriorcoating of the catheter is a hydrophilic coating.
 14. The method ofclaim 1, wherein the swelling medium does not contain any hydrophilicpolymers and/or any buffer components.